The legal requirements around seed and network structures are generating considerable confusion. Further guidance on legal considerations for different types of health organisations and appropriate organisational structures to meet the requirements of e-Health systems is also required. The legal status of seed organisations is one issue causing debate. Sites are being informed that a HPI-O seed organisation must be a legal entity. This is not specified in the HI Act or HI Regulations or PCEHR Regulations and Rules.
Legal advice was sought on this issue and advised that a seed organisation can either be a legal entity or part of a legal entity. The HI Service Operator cannot assign an HPI-O to a body which does not have legal capacity or is not part of an organisation which has legal capacity.
The advice17 noted that:
- A 'seed organisation' does not need to be the principal organisation in an organisation's governance structure (e.g. a seed organisation could be a hospital which is owned and ultimately controlled by a State health service). Compare this to a 'network organisation', which must be "part of or subordinate to"18 a seed organisation.
- A single legal entity (e.g. a State health service) can be assigned multiple Healthcare Identifiers for parts of its organisation. Some or all of those parts of the organisation can be registered as 'seed organisations'. In each case, the obligations which arise in connection with 'organisations' registration in the HI Service would fall on the legal entity and the nominated Responsible Officer and Organisation Maintenance Officer (who would be employees of the legal entity).
- An HPI-O cannot be assigned to a non-legal entity such as an ethics committee unless the ethics committee is part of a legal entity which provides healthcare (e.g. a hospital). If the ethics committee did apply to be assigned an HPI-O as a 'seed organisation', the obligations which arise in connection with its registration in the HI Service would fall on the legal entity (i.e. the hospital) and the nominated Responsible Officer and Organisation Maintenance Officer (who would be employees of the legal entity).
The basis for participation in the HI Service and the PCEHR system for corporate practices is also seen as unclear. For example there are GPs or specialists who aren’t employed by a practice, but who contract the practice to provide professional and/or administrative services. It is unclear to stakeholders how these practices might establish themselves in a HPI-O network structure, or whether they are able to use the CSP provisions to enable them to meet their obligations under the HI Act and the PCEHR Act and PCEHR (Consequential Amendments) Act.
Organisations also require additional information and support to make appropriate decisions about the structures they implement and the consequences of these decisions on downstream systems, particularly in relation to the way the organisation will be able to manage access controls for the PCEHR system19. There needs to be clear communication on the implications and responsibilities of the Responsible Officer and Organisation Maintenance Officer roles so that the expectations are clear.